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Influence of a new botanical combination on quality of life in menopausal Spanish women: Results of a randomized, placebo-controlled pilot study
- Source :
- PLoS ONE, PLoS ONE, Vol 16, Iss 7, p e0255015 (2021)
- Publication Year :
- 2021
- Publisher :
- Public Library of Science (PLoS), 2021.
-
Abstract
- Background This study was designed to evaluate the beneficial effects of a botanical extract combination containing soy isoflavone extract (100mg), Aframomum melegueta seed dry extract (50 mg), and Punica granatum skin dry extract (100mg) on health-related Quality of Life in healthy Spanish menopausal women with hot flashes, anxiety, and depressive symptoms using the validated Cervantes Scale. Methods and results Fifty-seven outpatient women (45–65 years) with menstrual problems associated with climacteric syndrome were enrolled from April 2018 to April 2019 in the context of a prospective, placebo-controlled, double-blind study. Women were randomized to receive treatment with either the botanical combination (250 mg daily divided into two doses) or placebo for eight weeks. At the beginning and end of the study, health-related Quality of Life was assessed using the Cervantes Scale. Subjects treated with the botanical extract, compared to subjects in the placebo group, showed a significant improvement in the Global health-related Quality of Life score (38% [11.3–50.0]% vs. 18.8% [0–37.7]%; P = 0.04) on the Cervantes Scale and, specifically, in the menopause and health domain (13.6% [0–45.4]% vs. 40.7% [20.6–61.0]%; P = 0.05). By contrast, there were no significant changes in the psychic, sexuality, and couple relationship related domains of the Cervantes Scale. Patients who concluded the study did not report substantial side effects. Conclusion Short-term intake of the botanical combination improved the Global Quality of Life of climateric women, according to the Cervantes Scale. Since this is a pilot trial, results should be analysed with caution. Trial registration NCT04381026; ClinicalTrial.gov (retrospectively registered).
- Subjects :
- Male
European People
Spanish People
Physiology
Health Status
Emotions
Social Sciences
Pilot Projects
Pomegranate
law.invention
Endocrinology
0302 clinical medicine
Quality of life
Randomized controlled trial
Psychological Attitudes
law
Medicine and Health Sciences
Ethnicities
Psychology
Medicine
Aframomum melegueta
Hispanic People
030219 obstetrics & reproductive medicine
Multidisciplinary
Traditional medicine
biology
Depression
Middle Aged
Menopause
Research Design
030220 oncology & carcinogenesis
Punica
Anxiety
Female
medicine.symptom
Research Article
Drug Research and Development
Science
Research and Analysis Methods
Placebo
03 medical and health sciences
food
Double-Blind Method
Zingiberaceae
Mental Health and Psychiatry
Animals
Humans
Clinical Trials
Beneficial effects
Pharmacology
Endocrine Physiology
Mood Disorders
Plant Extracts
business.industry
Biology and Life Sciences
Pilot Studies
medicine.disease
biology.organism_classification
Rats, Inbred F344
food.food
Rats
Health Care
People and Places
Quality of Life
Population Groupings
Soybeans
Clinical Medicine
business
Subjects
Details
- ISSN :
- 19326203
- Volume :
- 16
- Database :
- OpenAIRE
- Journal :
- PLOS ONE
- Accession number :
- edsair.doi.dedup.....c6d147c91137ac1cf27d3a446adc0a86